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This is a single centre、single arm、open-label,to investigate the safety and efficacy of EPC transplantation in the brain
Full description
The purpose of this study is to evaluate the efficacy and safety of transplantation EPCs intervent subjests with cerebral hemorrhagic stroke.
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Inclusion criteria
Subjects ≥ 18 and ≤ 80 years of age
Subjects was confirmed cerebral hemorrhagic stroke, included at least one of risk factors(Hypertension, diabetes, coronary heart disease, high blood lipid), and Satisfied with one of the following conditions:
A. Significant stenosis (> 50%) of the intracranial and extracranial arteries or their branches due to atherosclerosis, or clinical or imaging manifestations of vascular blockage B. Head imaging (CT or MRI) : cerebral hemispheric infarct lesion diameter of > 1.5cm; Or there were more than 2 discontinuous lesions in the blood supply area of the same intracranial external artery.
C. Auxiliary examination: color ultrasonography, CTA, MRA or DSA of the blood vessels in the neck confirmed that the intracranial or extracranial stenosis was greater than or equal to 50%;
Serum creatinine ≤ 1.5 mg/dl ; Serum ALT/AST)≤2.5×ULN;ALB≥25g/L;
Serum creatinine≤ 176.8umol/L(2.0 mg/dl);
Prothrombin time(PT)≤15s,International standardization rates(INR)<1.7;
The glucose should be control between 2.8~22.2mmol/L(50~400mg/dl);
Adult patients were willing to use reliable contraceptives (such as condoms) and not to donate sperm throughout the study period and within three months of discharge
Subjects and the guardians able to undergo post-physical therapy/rehabilitation
Exclusion criteria
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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